Observation: Missing Raw Material Identification Labels for Paracetamol 500 mg
Company Name: AABBCC
Manufacturing Site: AABBCC
Inspection: WHO GMP Inspection
CAPA Reference No.: __________
Observation Date: __________
1. Context of Observation
During the WHO GMP inspection of AABBCC, the inspection team observed that one or more raw material containers associated with the manufacture of Paracetamol 500 mg did not bear the required identification labels in accordance with established Good Manufacturing Practices (GMP) and internal warehouse/material management procedures.
The observation specifically indicated deficiencies in visual identification and status Labelling of raw material containers, which are intended to ensure traceability and prevent mix-ups during dispensing and manufacturing operations. Although warehouse documentation, material receipt records, and inventory reconciliation confirmed the identity and traceability of the material, the physical absence of identification labels represented a procedural non-compliance.
An immediate investigation was initiated by the Quality Assurance (QA) department. The investigation included review of warehouse records, dispensing logs, batch manufacturing records, stock reconciliation, and CCTV records (where available). No evidence of material mix-up, incorrect dispensing, cross-contamination, or adverse impact on product quality was identified.
2. Root Cause Analysis (Detailed)
A multidisciplinary investigation was conducted using the 6M methodology.
A. Man (Personnel)
- Warehouse personnel failed to verify label presence during routine handling.
- Inadequate reinforcement of Labelling verification during shift handover.
- Refresher training on material identification requirements was not conducted at the planned frequency.
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-raw-material-identification-labels/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-raw-material-identification-labels/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-raw-material-identification-labels/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
Find below pages for complete report
Click the link to download the word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-raw-material-identification-labels/
